Diabetes MellitusNCT02564913
Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients
An observational study of Diabetes Mellitus, run by Changhua Christian Hospital.
Trial summary
In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- clinical evaluation
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators recruited the control group , the pre-DM group, and the DM group.
Who may be able to join
- diabetic patients(ac sugar>126mg/dl or HbA1c>6.5, twice)
- pre-diabetic patients(100mg/dl <ac sugar<126mg/dl, or 5.9<HbA1c<6.5)
- non-diabetic patients(ac sugar<100mg/dl )
Who cannot join
- acute infectious disease,
- cancer,
- End Stage Renal Disease
About this study
In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia, which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing hyperglycemia can also be associated with buccal alteration. The purpose of this study was to survey on tongue diagnosis and other examinations associated with diabetic mellitus.
- Conditions
- Diabetes Mellitus
- Being tested
- clinical evaluation
- Keywords
- tongue diagnosis, heart rate variability, nailfold videocapillaroscopy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described Receives: Other: clinical evaluation | |
| pre-DM group | Not described Receives: Other: clinical evaluation | |
| DM group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
tongue diagnosis
Measured: 1 year
heart rate variability
Measured: 1 year
nailfold videocapillaroscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startDec 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Chi Hsu, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564913
- Sponsor's protocol ID
- 111106
- Status last verified
- Sep 2015
- First submitted
- 29 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients
- ClinicalTrials.gov ID
- NCT02564913
- Acronym / sponsor ID
- 111106
- Conditions
- Diabetes Mellitus
- Keywords
- tongue diagnosis, heart rate variability, nailfold videocapillaroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia, which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing hyperglycemia can also be associated with buccal alteration. The purpose of this study was to survey on tongue diagnosis and other examinations associated with diabetic mellitus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: clinical evaluation |
| pre-DM group | – | Other: clinical evaluation |
| DM group | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators recruited the control group , the pre-DM group, and the DM group.
Key inclusion criteria (3 listed)
- diabetic patients(ac sugar>126mg/dl or HbA1c>6.5, twice)
- pre-diabetic patients(100mg/dl <ac sugar<126mg/dl, or 5.9<HbA1c<6.5)
- non-diabetic patients(ac sugar<100mg/dl )
Key exclusion criteria (3 listed)
- acute infectious disease,
- cancer,
- End Stage Renal Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical evaluation | Other | control group, pre-DM group |
Primary outcome
tongue diagnosis
Time frame: 1 year
heart rate variability
Time frame: 1 year
nailfold videocapillaroscopy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Changhua Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tongue diagnosis (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.